Every year, thousands of women undergo surgery for vaginal prolapse (falling). Prolapse of the vagina can comprise the descent of multiple surrounding structures, including the bladder, uterus (if no hysterectomy has been performed), vaginal apex (after hysterectomy), and rectum. Vaginal prolapse is the result of weakness of the ligaments and muscles that normally hold the vagina within the pelvis. Vaginal prolapse is associated with multiple risk factors, including child birth, medical disease, obesity, age, and hysterectomy. Vaginal prolapse can result in pain, sexual dysfunction, difficulty in having a bowel movement, urinary incontinence, vaginal ulceration, and/or other problems.
Sacrocolpopexy is presently considered the optimum surgical procedure to correct vaginal vault prolapse. In sacrocolpopexy a generally Y-shaped mesh (as disclosed in U.S. Pat. No. 6,592,515, comprising a pair of angled arms permanently bonded to an elongated stem) is used to hold the vagina in the correct anatomical position. Sacrocolpopexy may be performed as an open surgery by making an approximately 25 cm horizontal incision in the lower abdomen, which allows the surgeon to manually access the inter-abdominal organs. However presently sacrocolpopexy is typically performed laparoscopically, most desirably using robotic assistance.
Irrespective of open or laparoscopic approach, the procedure begins by pushing the vagina back into its natural position using a surgical sizer, which allows for exposure. Then a space is created between the vagina and bladder and also between the vagina and rectum so as to expose the vaginal apex. This is a time consuming part of the procedure and often a source of injury to the bladder. A small incision is then made in the peritoneum to expose the sacrum part of the hip bone. Then the peritoneal incision is opened all the way down to the previously exposed vaginal apex and the mesh inserted. The generally Y-shaped portion of the mesh is sutured to the apex of the vagina while the mesh stem is anchored to the sacrum using suturing or a bone screw, so that the mesh suspends the apex of the vagina from the sacrum. The entire peritoneal incision is then closed using standard suturing.
Other surgical repairs of the vaginal apex may be made using a completely vaginal operation, if the vagina is tacked to a structure other than the sacrum. While this avoids the complications of an abdominal route, in at least one reported study these repairs are associated with inferior results. A completely transvaginal route to the sacrum would be ideal, but is considered by many surgeons to have unacceptable safety issues.
According to the invention, a surgical procedure and device are provided that have many advantages compared to conventional sacrocolpopexy, including removing many of the “danger” or time-consuming steps that presently relegate sacrocolpopexy to experienced lapararoscopic or robotic surgeons.
The device according to the invention comprises a surgical implantable article comprising a two component mesh system with the components connectable together by a locking device, and a surgical spreader assembly. The mesh parts are of biocompatible material and may comprise a first (e.g. generally rectangular) component and a truncated stem, and a separate elongated base component.
In the surgical procedure according to the invention, the generally rectangular mesh component is placed vaginally, and the mesh base abdominally, and they are hooked together with the locking device during the procedure. The mesh base is placed using a unique passing technique that allows the base of the mesh to pass underneath the peritoneum, and avoids having to open up the entire peritoneal incision. After passing, the mesh base is anchored to the sacrum, such as by using conventional suturing or a bone screw and locking ring, other conventional techniques. The abdominal portion of the procedure is most desirably performed laparoscopically. Importantly, there is more than one component to vaginal prolapse [for example both apical descent and a cystocele (bladder drop) and/or rectocele], and according to the invention it is possible to perform a second procedure concurrently to effectively fix the additional defect(s).
More particularly, according to the invention there is provided a surgical implantable article comprising first and second mesh components of biocompatible material. The mesh components may be made of the same material(s) (e.g. biocompatible polypropylene) as the surgical implantable article described in U.S. Pat. No. 6,592,515, the disclosure of which is incorporated by reference herein. The first mesh component may be a generally rectangular component having a truncated stem including a first locking element. The second mesh component comprises an elongated base having distal and proximate ends, with a second locking element operatively associated with the distal end.
As possible modifications of the second mesh component are the following: At the distal end is also a housing unit to allow for stylette insertion. At the proximal end, the elongated base preferably has a thinned neck that allows it to be drawn through a locking ring attached to the sacrum, or a pair of arms, or a wider area, depending upon how the mesh base will be attached to the sacrum.
The first and second locking elements, when moved into operative association with each other, fit together to positively lock the first and second components together, typically for the life of the patient. Any conventional, or hereafter developed, locking element configuration that accomplishes that result is utilizable.
In addition to the surgical implantable article described above, the invention includes several embodiments that facilitate placement and anchoring of the mesh components. One of these includes a surgical spreader assembly comprising spreader jaws connected to a flexible shaft with a removable handle. A sheath is also provided, dimensioned to fit over the flexible shaft and jaws when the handle is removed. Also provided is a stylette which helps advance the mesh base through the sheath (a sheath and stylette per se are shown in U.S. Pat. No. 7,637,920).
Alternatively, the spreader assembly can be replaced with a blunt tip, flexible stylette, and sheath dimensioned to fit over the stylette. In this embodiment standard laparoscopic instruments would be used to mobilize the peritoneum prior to stylette placement.
According to another aspect of the invention there is provided a surgical procedure for repairing female sexual organ problems in a human patient comprising: a) exposing a patient's peritoneum; b) making a peritoneal incision; c) mobilizing the peritoneum; d) attaching a first mesh component with a first locking element to a portion of the patent; e) passing a second mesh component having a second locking element at a distal end, and a proximal end, underneath the peritoneum; f) moving the first and second locking elements together into locking relationship; g) anchoring the second mesh component to a part of the patient's body so that the mesh components suspend at least a portion of one of the patient's sexual organs; and h) closing the peritoneal incision.
In utilizing the procedure, g) may be practiced to anchor the second mesh component to the sacrum so that the mesh components suspend the vaginal apex from the sacrum; and d) may be practiced by attaching the first mesh component to the apex of the patient's vagina or to the cervix. Also, this surgical procedure may be practiced to repair vaginal prolapse, including apical descent, or vaginal vault or uterine descensus, and/or cystocele and rectocele.
According to another aspect of the invention there is also provided a surgical procedure for repairing vaginal prolapse, including apical descent (vaginal vault or uterine descensus), cystocele and rectocele. According to the procedure of the invention, the following are practiced: a) exposing a patient's peritoneum; b) making a peritoneal incision over the patient's sacrum; c) mobilizing the peritoneum; d) incising the patient's vagina and attaching the anterior and posterior surfaces of a first (e.g. generally rectangular) mesh component, with a truncated stem and first locking element, to the apex of the vagina; e) passing a mesh base component having a second locking element at a distal end, and a proximal end, underneath the peritoneum; f) moving the first and second locking elements together into locking relationship; g) anchoring the mesh base to the sacrum, so that the mesh components suspend the vaginal apex from the sacrum; and h) closing the peritoneal incision.
In the practice of the surgical procedure according to the invention, d) is preferably practiced vaginally, and e) and g) abdominally. Anchoring may be practiced using a variety of conventional techniques, including standard suturing, or using a conventional bone screw affixed to the sacrum and a locking ring affixed to the bone screw, and the mesh base is tensioned using the locking ring and then fixed to the locking ring. Also, c) may be practiced using standard lap equipment, or by passing a spreader, having jaws connected to a flexible shaft underneath the peritoneum, the spreader also having a removable handle, and e) may be practiced by removing the handle of the spreader, passing a sheath over the spreader shaft and jaws to the approximate location of the first locking element, removing the spreader shaft and jaws through the sheath, and using a stylette inserting the base mesh through the sheath so that the second locking element is adjacent the first locking element.
In the procedure e)-g) are preferably performed laparoscopically. Further, a)-h) may be practiced to repair an apical descent, and additionally, prior to g) and h), the procedure may include i) repairing a cystocele and/or rectocele vaginally using altered vaginal mesh components, e.g. having anterior or posterior arms.
The invention can also be practiced to perform laparoscopically assisted vaginal hysteropexy by attached a modified first mesh component to the cervix.
There are numerous advantages of the invention compared to conventional sacrocolpopexy. These advantages include:
Avoids having to create a space between vagina/bladder, vagina/rectum. This is a source of injury to the bladder and is a time consuming part of the procedure. When it is done vaginally, it is also easier.
Avoids the need for laparoscopic suturing. The lack of this difficult skill is a significant reason why this surgery is done by a select number of gynecologists/urologists. The inventive procedure avoids several steps where laparoscopy is historically required (suturing mesh to vagina, suturing mesh to sacrum, closing the peritoneal incision).
Avoids difficulty in tensioning the mesh. The mesh tension is assessed by looking in the vagina before the final anchor is placed in the sacrum. This is extremely difficult when using a robot (which is docked between the patient's legs and obstructs vaginal access).
Allows for easy repair of concurrent cystocele/rectocele, if applicable. This usually requires completing the entire abdominal cases and then transitioning to a vaginal surgery. Alternatively, some people try to get the Y-arms far enough down to fix these defects, thereby increasing the risk of bladder or rectal injury. According to the invention, one just extends the vaginal incision to expose and fix the other defects.
The invention is easily practiced using many existing off the shelf components (e.g. the bone screw, locking ring, and cystocele obturator fascia anchors). However, according to the invention, conventional components can easily be replaced with other technology. Or, one can avoid the need for a bone screw and locking ring (or any technology) by just suturing the mesh into the sacrum (still a lot less suturing than usually required).
Allows for development in combination with novel techniques. Gaining momentum is “single-port” laparoscopy. This is putting all of the instruments through one port, one incision. Usually, laparoscopic sacrocolpopexy requires at least five incisions. The less complicated the procedure, the more likely it can be done. Removing all the suturing through the use of the “passing” technique of the invention makes a single-port approach even more accessible.
It is the primary object of the invention to provide improved procedures and devices for repairing vaginal prolapse, and related conditions. This and other objects of the invention will become clear from the detailed description of the invention, and from the appended claims.